MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number GSXE0030B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Fever (1858); Sepsis (2067)

Event Date 08/18/2021

Event Type  Injury  

Event Description

It was reported the physician selected a 30mm gore® cardioform septal occluder to treat a multifenestrated patent foramen ovale on (b)(6) 2021.The same evening, the patient was suffering from fever and over the next two days developed sepsis.Device imaging showed vegetative growth on both sides of the occluder.The device was explanted and the defect surgically closed (b)(6) 2021.2412-a:-dissatisfaction/non-specific (fever).1735-a:-bacterial infection/non-specific (sepsis).

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use list endocarditis as a potential device- or procedure-related adverse event.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12460142
• MDR Text Key: 271048216
• Report Number: 2017233-2021-02366
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: GSXE0030B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention